The DermaClip device is an “Rx Only” device. To order Rx devices, fill out the Customer Setup Form and a member of the team will confirm your eligibility.
DermaQuik is an over-the-counter version of DermaClip available to anyone. Perfect for first aid kits, the one-handed closure device can be used by anyone, anytime, and anywhere skin needs to be closed.
DermaClip and DermaQuik devices do not contain natural rubber latex.
DermaClip only uses top-of-the-line, long-duration, pressure sensitive, alkylate-based adhesives. Data sheets on the products are on file with the Company. There is no need to use adhesive enhancers.
DermaClip® is classified as a “Tape and Bandage, Adhesive” in product code KGX by the FDA. The KGX product code is Class 1, 510(k) exempt. DermaClip® has confirmed its classification with the FDA and is a registered device.
DermaQuik® is classified as a “Tape And Bandage, Adhesive, Adjustable Closing Mechanism, Otc Use” in product code PYO by the FDA. The PYO product code is Class 1, 510(k) exempt.
There are 3 main components of DermaClip®, all of which are manufactured and purchased in the US. The device utilizes two medical grade adhesives that are registered with the FDA. Additionally, a food grade plastic is used in production which is sourced from a US-based petrochemical facility. The device is assembled in Mexico.
The manufacturing facilities are registered with the FDA and comply with the Good Manufacturing Practices (“GMP”) described by the US FDA’s Quality Systems Regulation (“QSR”), as required by the product’s classification.
The manufacturing facilities are FDA registered and are subject to US FDA’s QSR. In addition, the manufacturing operations have been certified as complying with international standards for the manufacturing of medical devices, having earned ISO 13485 certification.